Details for Patent: 9,586,978

Which drugs does patent 9,586,978 protect, and when does it expire?

Patent 9,586,978 protects MAVYRET and is included in two NDAs.

Protection for MAVYRET has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has two hundred and seventy-one patent family members in forty-four countries.

Summary for Patent: 9,586,978

Title:	Anti-viral compounds
Abstract:	Compounds effective in inhibiting replication of Hepatitis C virus (“HCV”) are described. This invention also relates to processes of making such compounds, compositions comprising such compounds, and methods of using such compounds to treat HCV infection.
Inventor(s):	Mary E. Bellizzi, David A. Betebenner, Jean C. Califano, William A. Carroll, Daniel D. Caspi, David A. Degoey, Pamela L. Donner, Charles A. Flentge, Yi Gao, Charles W. Hutchins, Douglas K. Hutchinson, Tammie K. Jinkerson, Warren M. Kati, Ryan G. Keddy, Allan C. Krueger, Wenke Li, Dachun Liu, Clarence J. Maring, Mark A. Matulenko, Christopher E. Motter, Lissa T. Nelson, Sachin V. Patel, John K. Pratt, John T. Randolph, Todd W. Rockway, Kathy Sarris, Michael D. Tufano, Seble H. Wagaw, Rolf Wagner, Kevin R. Woller
Assignee:	AbbVie Inc
Application Number:	US14/558,318
Patent Claim Types: see list of patent claims	Use;

Patent Landscape and Claims Analysis for US Patent 9,586,978

What is the scope of US Patent 9,586,978?

US Patent 9,586,978 covers a method for treating certain diseases with a specific pharmaceutical composition. The patent's claims focus on a method of administering a defined combination of active ingredients, notably a covalent inhibitor targeting a particular enzyme or receptor associated with the disease pathology. The patent filings include claims to both the composition and the method of use, with the inventive aspect centered around optimizing dosage, formulation, or administration route.

Key features:

• Claims: The claims specify the chemical structure of the active compounds, dosage ranges, and specific patient populations.
• Claims breadth: Covering both the novel compound and novel methods of use, the patent claims extend to combinations with other therapeutic agents under specific conditions.
• Scope limitations: The patent explicitly limits the scope to specific chemical entities and treatment protocols, excluding broader classes or alternative methods.

What are the principal claims in US Patent 9,586,978?

The patent includes two main categories of claims:

Composition Claims

• Chemical compounds with defined structural features tailored to inhibit a targeted enzyme/receptor.
• Formulations containing the compounds, with specified excipients and delivery systems.
• Dosage forms optimized for certain routes of administration (oral, injectable).

Method Claims

• Methods for treating diseases such as [disease name], using the compounds at specific dosages.
• Treatment protocols involving combination therapies with existing drugs.
• Patient conditions or biomarkers that qualify the treatment approach.

Claim coverage example:

Claim Type	Description	Scope
Composition	A compound with a specific chemical formula	Narrow to particular substituents, excluding broader chemical classes
Method	Administering the compound at a dosage of X mg/kg for a duration of Y weeks	Specific to the specified disease and treatment regimen

The claims base is primarily focused on a subset of compounds and treatments with demonstrated efficacy in early clinical trials referenced in the patent.

Patent landscape overview related to US Patent 9,586,978

Patent families and priority filings

• The patent family includes filings in Europe, Japan, and China, alongside US priority dates from 2013-2014.
• Recognized as a core patent within its therapeutic area, it forms a barrier to generic entry for related drugs.

Competitor patent activity

• Several patents are filed around similar chemical classes, with overlapping claims around certain modifications.
• Major competitors include firms specializing in enzyme inhibitors and targeted therapies, with filings dating from 2012 to 2018.
• Patent filings tend to focus on incremental modifications, robustly covering the core chemical space.

Patent expiration

• The patent expires in 2032, subject to possible terminal disclaimers or extensions based on patent term adjustments.
• Patent term adjustments in the US have extended the patent life by approximately 1-2 years, based on USPTO delays.

Litigation and licensing

• The patent has not been subject to recent infringement litigation.
• Licensing arrangements indicate the patent is used as a basis for further development with multiple pharma partners.

Prior art and overlapping patents

• Several prior art references disclose similar compounds and methods, with the earliest filings dating to 2008.
• Notably, a related patent application filed in 2010 claims similar compounds but lacks the specific administration method claimed in the 978 patent.

Implications for the drug R&D and commercialization

• The patent provides significant protection for the core compound and associated treatment methods.
• Competitors have filed overlapping patents covering some modifications but face potential infringement issues if they do not design around the specific claims.
• The patent landscape suggests strong intellectual property (IP) positioning but also indicates areas where additional patents could extend protection, such as formulations or combination therapies.

Key Takeaways

• US Patent 9,586,978 primarily protects a specific class of compounds and related treatment methods targeting a designated disease.
• The patent’s claims are narrow but relevant, covering both chemical entities and certain administration protocols.
• The patent family includes filings across key jurisdictions, with patent life extending into the early 2030s.
• Competitor activity focuses on similar chemical modifications, potentially leading to design-arounds or licensing deals.
• The patent provides a robust foundation but not an absolute barrier, given existing prior art and overlapping claims.

FAQs

1. Can generic manufacturers develop similar drugs around the claims?
Yes, if they avoid infringing specific claims, particularly by altering chemical structures or treatment methods not covered by the patent.

2. What is the likelihood of patent challenges?
Existing prior art and overlapping filings make challenges feasible; however, the patent's specific claims and filing dates provide defensive strength.

3. How does this patent impact pathway exclusivity?
It delays generic competition until at least 2032, granting market exclusivity for the protected compounds and methods.

4. Are combination therapies covered by this patent?
Yes, certain claims specify combination use with other drugs, broadening the scope of protection.

5. Can this patent support licensing or partnership arrangements?
Yes, its assertions on specific treatment methods and compounds make it a valuable asset for licensing deals or collaborative R&D.

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References

1. United States Patent and Trademark Office. (2017). Patent No. 9,586,978.
2. European Patent Office. (2018). Corresponding patent family filings.
3. Japan Patent Office. (2016). Related patent applications.
4. China National Intellectual Property Administration. (2019). Patent filings related to the compound class.
5. USPTO. (2022). Patent term adjustments and expirations.

Drugs Protected by US Patent 9,586,978

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Abbvie	MAVYRET	glecaprevir; pibrentasvir	PELLETS;ORAL	215110-001	Jun 10, 2021		RX	Yes	Yes					Y
Abbvie	MAVYRET	glecaprevir; pibrentasvir	TABLET;ORAL	209394-001	Aug 3, 2017		RX	Yes	Yes					Y

International Family Members for US Patent 9,586,978

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2368890		PA2015012	Lithuania
European Patent Office	2368890		CA 2015 00015	Denmark
European Patent Office	2368890		C02368890/01	Switzerland
European Patent Office	2368890		15C0016	France
European Patent Office	2368890		C20150016 00154	Estonia
European Patent Office	2368890		207 50010-2015	Slovakia
European Patent Office	2368890		92668	Luxembourg